Pain in Patients With Dementia and Behavioural Disturbances
NCT01021696 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 352
Last updated 2011-08-10
Summary
In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.
It was hypothesized that
* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia
Conditions
Interventions
- DRUG
-
Paracetamol Max. dose: 3g/d
- DRUG
-
Morphine
Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d
- DRUG
-
Buprenorphine plaster
5ųg/h, change each 7.day; max. dose: 10ųg/h
- DRUG
-
Pregabalin
25mgx1/d; max 300mg/d
Sponsors & Collaborators
-
The Research Council of Norway
collaborator OTHER -
University of Bergen
lead OTHER
Principal Investigators
-
Rolv Terje Lie, PhD · University of Bergen, Norway
-
Bettina S. Husebo, MD, PhD · University of Bergen, Norway
-
Dag Aarsland, MD, Phd · University of Bergen, Norway
-
Clive Ballard, MD, PhD · King's College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2010-07-31
- Completion
- 2010-10-31
Countries
- Norway
Study Locations
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